Alfuzosin for Treating Acute Urinary Retention - Full Text View

Purpose

The primary objective of the study is to assess the efficacy of alfuzosin 10mg daily in the return to successful voiding after removal of the catheter following a first episode of acute urinary retention (AUR) in patients suffering from benign prostatic hyperplasia (BPH).

Condition	Intervention	Phase
Acute Urinary Retention	Drug: Alfuzosin Drug: Placebo	Phase III

ChemIDplus related topics:

Alfuzosin Alfuzosin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	A Double-Blind, Randomized,Placebo Controlled Study of Alfuzosin 10mg od in the Return to Successful Voiding in Patients With a First Episode of Acute Urinary Retention Due to Benign Prostatic Hyperplasia

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Percentage of patients with successful voiding after catheter removal [ Time Frame: Day 3 and 4 ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: Yes ]

Enrollment:	156
Study Start Date:	February 2006
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Alfuzosin 10mg	Drug: Alfuzosin Once daily
2: Placebo Comparator Placebo	Drug: Placebo Once daily

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

First episode of painful AUR related to BPH requiring catheterization
Residual volume between 500ml and 1500ml obtained at the time of catheterization and during the first one hour after catheterization

Exclusion Criteria:

Participated in another investigational study within 3 months before recruitment
Suspect bladder neuro-dysfunction unrelated to etiology;
Single Bladder neck disease;
Acute/chronic prostatitis;
Diagnosed prostate carcinoma;
Suspected prostate carcinoma diagnosed by ultrasound wave;
Surgical history of prostate and urethra;
Diagnosed/suspected abnormality in urethra structure;
Bladder stone;
Blood urine retention caused by any reason;
Residual volume less than 500 ml
Residual volume more than 1500 ml
AUR not due to BPH
Parkinson's disease
Insulin dependent diabetes
Known/suspected multiple sclerosis;
Stroke/MI within 6 months prior to enrolment;
AST, ALT and Creatinine > 1.5x upper limit; neutrophil < 3,000/mm³; platelet < 100,000/mm³;
Unstable/severe heart failure;
History of postural hypertension/hypotension;
Known hypersensitivity to α-receptor blocker;
Suspected/diagnosed expansible nerval disease;
Treatment with sympathomimetic agent within 1 week prior to enrolment, except OTC drug for cold intermittently;
Treatment with α1-receptor blocker within 1 month prior to enrolment;
Treatment with tricyclic antidepressants, anticholinergic agents, sympathomimetic agent (other than the above reason), first generation antihistaminic, except the treatment with stable β sympathomimetic agent/ anticholinergic agents lasting more than 1 week for Asthma and COPD (Chronic Obstructive Pulmonary Disease);
Treatment with Disopyramide

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336921

Locations


China
	Sanofi-aventis
	Beijing, China

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	Bruno Jolain	Sanofi-Aventis

More Information

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	L_9645
First Received:	June 14, 2006
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00336921
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Hyperplasia

Alfuzosin

Prostatic Diseases

Urologic Diseases

Prostatic Hyperplasia

Urination Disorders

Genital Diseases, Male

Urinary Retention

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Therapeutic Uses

Physiological Effects of Drugs

Adrenergic Antagonists

Cardiovascular Agents

Adrenergic alpha-Antagonists

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00336921